Tasche M J, Uijen J H, Bernsen R M, de Jongste J C, van der Wouden J C
Department of General Practice, Erasmus University, 3000 DR Rotterdam, The Netherlands.
Thorax. 2000 Nov;55(11):913-20. doi: 10.1136/thorax.55.11.913.
Disodium cromoglycate (DSCG) is included in the BTS guidelines on the treatment of asthma for use in children, but is now used only infrequently. We have identified and interpreted the findings of all published randomised, placebo controlled trials of DSCG in the prophylactic treatment of children with asthma.
Several databases were searched to identify trials. Studies were included if they investigated subjects with asthma aged 0-18 years old, addressed maintenance treatment with inhaled DSCG, and were published in English. The methodological quality of the studies was assessed independently by three reviewers. The 95% confidence intervals (CI) of differences in the treatment effect for cough and wheeze between placebo and treatment with DSCG were computed. The estimates were pooled and tested for homogeneity and, to assess possible publication bias, a funnel plot was made and tested for symmetry.
Of the 24 randomised, placebo controlled trials identified, the methodological scores varied widely. The null hypothesis of homogeneity was rejected. Under the assumption of heterogeneity the overall CI for wheeze was 0.11 to 0.26 and for cough was 0.13 to 0.27. The overall tolerance intervals (-0.11 to 0. 48 and -0.04 to 0.43 for wheeze and cough, respectively) both included zero, so it cannot be concluded that future studies will show an effect of DSCG compared with placebo. Older studies were more often in favour of DSCG. The funnel plots suggest publication bias; small studies with negative or equal outcomes are lacking.
Given the apparent publication bias, the small overall treatment effect, and the tolerance interval including zero, there is insufficient evidence that DSCG has a beneficial effect as maintenance treatment in children with asthma.
色甘酸钠（DSCG）被纳入英国胸科学会（BTS）关于儿童哮喘治疗的指南，但目前使用较少。我们已识别并解读了所有已发表的关于DSCG预防性治疗儿童哮喘的随机、安慰剂对照试验的结果。
检索了多个数据库以识别试验。纳入的研究需调查0至18岁的哮喘患者，涉及吸入DSCG的维持治疗，且以英文发表。三位评审员独立评估研究的方法学质量。计算安慰剂组和DSCG治疗组在咳嗽和喘息治疗效果差异的95%置信区间（CI）。汇总估计值并检验同质性，为评估可能的发表偏倚，绘制漏斗图并检验其对称性。
在识别出的24项随机、安慰剂对照试验中，方法学得分差异很大。同质性的零假设被拒绝。在异质性假设下，喘息的总体CI为0.11至0.26，咳嗽的总体CI为0.13至0.27。总体耐受区间（喘息和咳嗽分别为-0.11至0.48和-0.04至0.43）均包含零，因此不能得出未来研究将显示DSCG与安慰剂相比有效果的结论。较早期的研究更倾向于DSCG。漏斗图提示存在发表偏倚；缺乏结果为阴性或相同的小型研究。
鉴于明显的发表偏倚、总体治疗效果较小以及耐受区间包含零，没有足够的证据表明DSCG作为儿童哮喘的维持治疗有有益效果。
